The South African Medical Association (SAMA) says it has noted the publishing of the contentious “Certificate of Need for Health Establishments and Health Agencies” regulations and again raised its concerns about this proposed legislation. Published in the Government Gazette on 15 June for comment, the regulations seek to activate provisions in the National Health Act which require a Certificate of Need (CoN) to run, establish, construct, modify, or acquire a health establishment.

 The initial period for commentary on the regulations has been extended from 15 July to 15 August, following objections from various stakeholders, including SAMA. The association has now asked members to participate in a survey about the regulations (information below) while also asking interested parties to submit their comments to Bernard Mutsago at by no later than next Wednesday (11 August 2021).

“Firstly, we are disappointed at the sudden, surreptitious publication of the regulations without prior notification. That aside, SAMA has serious concerns about the implication of this legislation, particularly as we believe they could be detrimental in the provision of health services in a country already struggling to provide these services effectively. Introducing these regulations could, we believe, have the unintended consequence of unnecessarily closing doctors’ practices, and triggering an exodus of doctors to other countries,” says SAMA Chairperson Dr Angelique Coetzee.

In addition, Dr Coetzee says the regulations could create barriers of entry into the market by reducing competition which will cause a rise in healthcare costs which will be unaffordable for the majority of South Africans.

“We further believe that the constitutional rights of individual medical doctors, such as freedom of movement and residence, freedom of trade, occupation and profession, the right to property, and the right to human dignity, will be negatively impacted. We simply cannot abide by these proposals, and they should urgently be rescinded.”

Of equal concern, she says, is the fact the legislation gives unfettered powers to the health minister over the health industry and denies patients the right to be serviced by a medical doctor or establishment of their choice.

SAMA says that should the CoN regulations be implemented; existing medical practices would be under threat as they will not be allowed to continue their business without applying for – and being granted – a certificate of need to render services in a government-approved geographic area.

Current proposals are that existing health establishments – if they are granted approval – would receive a certificate of need which is valid for only three years. New establishments would receive certificates valid for 20 years, but these would have to be renewed annually.

“Of concern, is that these Certificates of Need can be revoked at any time by government who would, effectively, create criminals out of doctors overnight. This is because the failure to obtain a CoN carries a prison sentence of up to five years, or an as yet unspecified fine amount, or both. We cannot allow such a situation to occur, not only for the sake our members, but, more importantly, for the sake of their patients,” says Dr Coetzee.

Dr Coetzee says SAMA has spoken of these and other concerns in its interactions with the Minister and Director-General of Health.

“Despite these engagements we are still faced with an extraordinarily short time in which to make formal submissions on this matter. The brief period to provide commentary illustrates the DoH’s insensitivity towards its stakeholders, including SAMA. We are a member-based association and, as such, we must have widespread and exhaustive consultations to ensure we accurately represent the interests of all our members across various disciplines. This timeframe does not adequately allow for that outcome,” says Dr Coetzee.

Dr Coetzee says the concerns around the timing of the submissions are shared by other medical and health bodies but that despite the DoH’s assurance that the process would not proceed without consultation, this appears to be and attempt to limit that consultation. She says SAMA urges the DoH to reconsider its timeframes especially as it believes the department should work with other stakeholders instead of only reviewing their submissions on the CoN regulations.

SAMA says in the event that its negotiations with government on this issue breakdown, it will have no alternative but to partner with other affected stakeholders to find reasonable solutions, and to take appropriate action. It says it will attempt to avoid taking a legal route as far possible but that it may have to consider this an option if a reasonable solution is not forthcoming.

“Ultimately, we cannot comment on the present regulations without referring to the original CoN provisions contained the National Health Act of 2003 which reflect more clearly the intentions of the CoN, and which contain more comprehensive criteria for awarding or denying such certificates to be issued. However, even these are confounded by certification processes and standards of the Office of Health Standards Compliance, and we will change these,” concludes Dr Coetzee.

To access the survey, go to:

SAMA’s draft submission on the regulation
is available on:

Source: SAMA media release